Drug Master Files for: CHOLINE FENOFIBRATE
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CHOLINE FENOFIBRATE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10598 | I | II | 12/2/1993 | GENZYME PHARMACEUTICALS | SN-1, 2-DIPALMITOY1-3-PHOSPHATIDYLCHOLINE (DPPC) |
11247 | A | IV | 12/12/1994 | LIPOID GMBH | LIPOID PC 14:0/14:0 (1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DMPC)) |
11407 | I | II | 3/28/1995 | AVANTI POLAR LIPIDS INC | 1,2-DIMYRISTOYL-SN-GLYCERO-3-PHOSPHOCHOLINE |
11464 | A | II | 4/12/1995 | NOF CORP | DIMYRISTOYL PHOSPHATIDYL CHOLINE |
11561 | I | II | 5/31/1995 | NOF CORP | PURIFIED EGG YOLK PHOSPHATIDYLCHOLINE |
11592 | I | II | 7/20/1995 | LOHMANN THERAPIE SYSTEME GMBH AND CO KG | CHOLINERGIC CHANNEL ACTIVATOR-TRANSDERMAL DELIVERY SYSTEM |
>DMF No. | >Status | >Type | >Submission Date | >Holder | >Subject |
Drug Master File Glossary
STATUS OF DMFS
- A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
- I = Inactive
- N = Not an assigned number
- P = DMF Pending Filing Review
TYPES OF DMFs
- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III Packaging Material
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V FDA Accepted Reference Information